KLARICID 500 MG

Active substance: CLARITHROMYCIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
KLARICID® 500mg
(Clarithromycin)
This product is available in above name and strength but will be
referred to as Klaricid throughout the remainder of this leaflet.]
This product is also available in other strengths.
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Klaricid tablets are and what they are used for
2. Before taking Klaricid tablets
3. Taking Klaricid tablets
4. Possible side effects
5. How to store Klaricid tablets
6. Further information
1. What Klaricid tablets are and what they are used for
Each Klaricid tablet contains 250 mg or 500 mg of the active ingredient
clarithromycin.
Klaricid belongs to a group of medicines called macrolide antibiotics.
Antibiotics stop the growth of bacteria (bugs) which cause infections.
Klaricid tablets are used to treat infections such as:
1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and tissue infections
4. Helicobacter pylori infection associated with duodenal ulcer
Klaricid Tablets are indicated in adults and children 12 years and older. 2.
2. Before taking Klaricid tablets
Do not take Klaricid tablets if you;
 know that you are allergic to clarithromycin, other macrolide antibiotics
such as erythromycin or azithromycin, or any of the other ingredients in
the tablets.
 are taking medicines called ergotamine or dihydroergotamine tablets or
use ergotamine inhalers for migraine.
 are taking medicines called terfenadine or astemizole (widely taken for
hay fever or allergies) or cisapride (for stomach disorders) or pimozide
(for mental health problems) as combining these drugs can sometimes
cause serious disturbances in heart rhythm.
 are taking lovastatin or simvastatin (HMG-CoA reductase inhibitors,
commonly known as statins, used to lower levels of cholesterol (a type
of fat) in the blood).
 have low levels of potassium in the blood (a condition known as
hypokalaemia).
 have severe liver disease with kidney disease.
 have an irregular heart rhythm.
Klaricid tablets are not suitable for use in children under 12 years of
age.
Take special care with Klaricid tablets;
 if you have any liver or kidney problems
 if you have, or are prone to, fungal infections (e.g. thrush)
 if you are pregnant or breast feeding
If any of these apply to you, consult your doctor before taking Klaricid
tablets.
Taking other medicines
You should not take Klaricid tablets if you are taking any of the medicines
listed in the section above “Do not take Klaricid tablets if you;”
Tell your doctor if you are taking any of the following medicines as your
dose may need to be changed or you may need to have regular tests
performed:
 digoxin, quinidine or disopyramide (for heart problems)
 warfarin (for thinning the blood)
 carbamazepine, valproate, phenobarbital or phenytoin (for epilepsy)
 atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly
known as statins, and used to lower levels of cholesterol (a type of fat)
in the blood)
 colchicine (usually taken for gout)
 nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to
lower blood glucose levels)
 theophylline (used in patients with breathing difficulties such as asthma)
 triazolam, alprazolam or midazolam (sedatives)

 cilostazol (for poor circulation)
 omeprazole (for treatment of indigestion and gastric ulcers) unless your
doctor has prescribed it for you to treat Helicobacter pylori infection
associated with duodenal ulcer
 methylprednisolone (a corticosteroid)
 vinblastine (for treatment of cancer)
 ciclosporin, sirolimus and tacrolimus (immune suppressants)
 efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir
(anti-viral drugs used in the treatment of HIV)
 rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used in the
treatment of certain bacterial infections)
 tolterodine (for overactive bladder)
 verapamil (for high blood pressure)
 sildenafil, vardenafil and tadalafil (for impotence in adult males or for
use in pulmonary arterial hypertension (high blood pressure in the
blood vessels of the lung))
 St John’s Wort (a herbal product used to treat depression)

4. Possible side effects

6. Further information

Like all medicines, Klaricid tablets can cause side effects although not
everybody gets them.
If you suffer from any of the following at any time during your treatment
STOP TAKING your tablets and contact your doctor immediately:
 severe or prolonged diarrhoea, which may have blood or mucus in it.
Diarrhoea may occur over two months after treatment with
clarithromycin, in which case you should still contact your doctor.
 a rash, difficulty breathing, fainting or swelling of the face and throat.
This is a sign that you may have developed an allergic reaction.
 yellowing of the skin (jaundice), skin irritation, pale stools, dark urine,
tender abdomen or loss of appetite. These may be signs that your liver
may not be working properly.
 severe skin reactions such as blistering of the skin, mouth, lips, eyes
and genitals (symptoms of a rare allergic reaction called
Stevens-Johnson syndrome/toxic epidermal necrolysis).

What Klaricid tablets contain
Each Klaricid tablet contains 500 mg of the active ingredient clarithromycin.

Klaricid does not interact with oral contraceptives.

Common side effects of Klaricid tablets include;
 headache
 difficulty sleeping
 changes in sense of taste
 stomach problems such as feeling sick, vomiting, stomach pain,
indigestion, diarrhoea
 a change in the way the liver works
 skin rash
 increased sweating

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or if you are
breast-feeding, consult your doctor before taking Klaricid tablets as the
safety of Klaricid tablets in pregnancy and breast-feeding is not known.
Driving and Using Machines:
Klaricid tablets may make you feel dizzy or drowsy. If they affect you in this
way do not drive, operate machinery or do anything that requires you to be
alert.
3. Taking Klaricid tablets
Do not give these tablets to children under 12 years. Your doctor will
prescribe another suitable medicine for your child.
Always take Klaricid tablets exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. The usual dose is;
For chest infections, throat or sinus infections and skin and soft
tissue infections:
Usual dose of Klaricid tablets for adults and children over 12 years is 250
mg twice daily for 6 to 14 days, e.g. one 250 mg tablet in the morning and
one in the early evening. Your doctor may increase the dose to 500 mg
twice daily in severe infections.
Klaricid tablets should be swallowed with at least half a glass of water.
For the treatment of Helicobacter pylori infection associated with
duodenal ulcers:
There are a number of effective treatment combinations available to treat
Helicobacter pylori in which Klaricid tablets are taken together with one or
two other drugs.
These combinations include the following and are usually taken for 6 to 14
days:
a) One Klaricid 500 mg tablet taken twice a day together with amoxycillin,
1000 mg taken twice a day plus lansoprazole, 30 mg twice a day.
b) One Klaricid 500 mg tablet taken twice a day together with metronidazole, 400 mg taken twice a day plus lansoprazole, 30 mg twice a day.
c) One Klaricid 500 mg tablet taken twice a day together with amoxycillin,
1000 mg taken twice a day or metronidazole, 400 mg taken twice a day
plus omeprazole, 40 mg a day.
d) One Klaricid 500 mg tablet taken twice a day together with amoxycillin,
1000 mg taken twice a day plus omeprazole, 20 mg taken once a day.
e) One Klaricid 500 mg tablet taken three times a day together with omeprazole 40 mg taken once a day.
The treatment combination that you receive may differ slightly from the
above. Your doctor will decide which treatment combination is the most
suitable for you. If you are unsure which tablets you should be taking or
how long you should be taking them for, please consult your doctor for
advice.
If you take more Klaricid tablets than you should
If you accidentally take more Klaricid tablets in one day than your doctor
has told you to, or if a child accidentally swallows some tablets, contact
your doctor or nearest hospital emergency department immediately. An
overdose of Klaricid tablets is likely to cause vomiting and stomach pains.
If you forget to take Klaricid tablets
If you forget to take a Klaricid tablet, take one as soon as you remember.
Do not take more tablets in one day than your doctor has told you to.
Do not stop taking Klaricid tablets, even if you feel better. It is important to
take the tablets for as long as the doctor has told you to, otherwise the
problem might come back.
4. Possible side effects

Other less common side effects include:
 swelling, redness or itchiness of the skin. Sometimes brown scales may
appear
 acne
 oral or vaginal ‘thrush’ (a fungal infection)
 reduction in the level of certain blood cells (which can make infections
more likely or increase the risk of bruising or bleeding)
 loss of appetite, heartburn, bloating, constipation, wind
 inflammation of the pancreas
 anxiety, nervousness, drowsiness, tiredness, dizziness, tremor or
shaking
 confusion, loss of bearings, hallucinations (seeing things), change in
sense of reality or panicking, depression, abnormal dreams or
nightmares
 convulsion (fits)
 ringing in the ears or hearing loss
 vertigo
 leaking of blood from blood vessels (haemorrhage)
 inflammation of the mouth or tongue
 discolouration of the tongue or teeth
 dry mouth
 loss of taste or smell or inability to smell properly
 joint pain
 muscle pain or loss of muscle tissue. If you suffer from myasthenia
gravis (a condition in which the muscles become weak and tire easily)
clarithromycin may worsen these symptoms
 chest pain or changes in heart rhythm such as palpitations
 a change in the levels of products made by the liver, inflammation of
the liver or an inability of the liver to function properly (you may notice
yellowing of the skin, dark urine, pale stools or itchiness of the skin)
 a change in the levels of products produced by the kidney, inflammation
of the kidney or an inability of the kidney to function properly (you may
notice tiredness, swelling or puffiness in the face, abdomen, thighs or
ankles or problems with urination)
 low blood sugar levels
 a change in the levels of certain cells or products found in the blood.
Consult your doctor immediately if you develop any of these problems or
have any other unexpected or unusual symptoms.
5. How to store Klaricid tablets
Store in a dry place below 30 ºC. Protect from light.
Do not use these tablets after the expiry date printed on the carton or
blister labels.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Never give these tablets to someone else; they may harm them, even if
their symptoms are similar to yours.
If your tablets show any signs of deterioration or discolouration, seek the
advice of your pharmacist who will tell you what to do.
If the doctor decides to stop treatment, return any unused tablets to the
pharmacist for safe disposal. Only keep them if your doctor tells you to.

The inactive ingredients in the 500mg tablets are; propylene glycol,
quinoline yellow (aluminium lake) (E104), croscarmellose sodium, talc,
microcrystalline cellulose, colloidal hydrated silica, povidone, stearic acid,
magnesium stearate, hypromellose, titanium dioxide (E171), vanillin,
sorbic acid, sorbitan mono-oleate and hydroxypropyl cellulose
What Klaricid tablets look like and contents of the pack
Klaricid tablets are yellow and oval shaped.
Klaricid 500mg tablets are packed in two blister strips containing 7 tablets
each making a total of 14, or three blister strips containing 7 tablets each
making a total of 21 tablets.
Manufacturer
This product is manufactured by: Abbott S.p.A, Italy.
It is procured within the EU and repackaged by the Product Licence holder:
G-Pharma Ltd, Dakota Avenue, Salford M50 2PU.
POM

PL 16369/0080 – KLARICID® 500mg Tablet
18th May 2012

‘KLARICID’ is a registered trademark of Abbott Laboratories

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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